U.S. patent number 9,241,761 [Application Number 13/729,685] was granted by the patent office on 2016-01-26 for ablation probe with ultrasonic imaging capability.
This patent grant is currently assigned to Boston Scientific Scimed Inc., Koninklijke Philips N.V.. The grantee listed for this patent is Boston Scientific Scimed, Inc., Koninklijke Philips N.V.. Invention is credited to Szabolcs Deladi, Josef V. Koblish, Darrell L. Rankin.
United States Patent |
9,241,761 |
Rankin , et al. |
January 26, 2016 |
Ablation probe with ultrasonic imaging capability
Abstract
Devices and systems for ultrasonically imaging anatomical
structures and performing ablation therapy within the body are
disclosed. A combined ablation and ultrasound imaging probe
includes an ablation electrode tip including an ablation electrode
configured for delivering ablation energy, and a number of
ultrasonic imaging sensors configured for imaging the tissue
surrounding the probe. The ultrasonic imaging sensors are supported
within the interior of the tip via a tip insert, and deliver
ultrasonic waves through acoustic openings formed through the tip.
The tip insert separates an interior lumen within the tip into a
proximal fluid chamber and a distal fluid chamber. During an
ablation procedure, the ultrasonic imaging sensors can be tasked to
generate a number of ultrasonic images that can be displayed on a
user interface.
Inventors: |
Rankin; Darrell L. (Milpitas,
CA), Koblish; Josef V. (Sunnyvale, CA), Deladi;
Szabolcs (Veldhoven, NL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc.
Koninklijke Philips N.V. |
Maple Grove
Eindhoven |
MN
N/A |
US
NL |
|
|
Assignee: |
Koninklijke Philips N.V.
(Eindhoven, NL)
Boston Scientific Scimed Inc. (Maple Grove, MN)
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Family
ID: |
47604148 |
Appl.
No.: |
13/729,685 |
Filed: |
December 28, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130172742 A1 |
Jul 4, 2013 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61580705 |
Dec 28, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
18/1492 (20130101); A61B 8/445 (20130101); A61M
5/00 (20130101); A61B 8/54 (20130101); A61B
8/5207 (20130101); A61B 18/1206 (20130101); A61B
8/12 (20130101); A61B 8/4477 (20130101); A61B
2018/00982 (20130101); A61B 2217/007 (20130101); A61B
2018/00577 (20130101); A61B 2018/00821 (20130101); A61B
2090/3784 (20160201); A61B 2017/003 (20130101); A61B
2090/3966 (20160201); A61B 2018/00023 (20130101); A61B
2017/00106 (20130101) |
Current International
Class: |
A61B
8/00 (20060101); A61B 18/12 (20060101); A61B
8/12 (20060101); A61M 5/00 (20060101); A61B
8/08 (20060101); A61B 18/14 (20060101); A61B
18/00 (20060101); A61B 17/00 (20060101); A61B
19/00 (20060101) |
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|
Primary Examiner: Moher; Amanda Lauritzen
Assistant Examiner: Mohammed; Shahdeep
Attorney, Agent or Firm: Faegre Baker Daniels LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims priority to Provisional Application No.
61/580,705, filed Dec. 28, 2011, which is herein incorporated by
reference in its entirety.
Claims
What is claimed is:
1. An ablation probe for treating and imaging body tissue, the
ablation probe comprising: an ablation electrode tip including an
ablation electrode configured for delivering ablation energy to
body tissue; a plurality of acoustic openings disposed through the
ablation electrode tip; a distal tip insert disposed within an
interior lumen of the ablation electrode tip, the distal tip insert
including a plurality of fluid channels; and a plurality of
ultrasonic imaging sensors coupled to the distal tip insert, the
ultrasonic imaging sensors configured to transmit ultrasonic waves
through the acoustic openings, wherein the distal tip insert
includes a plurality of recesses each configured for receiving one
of the plurality of ultrasonic imaging sensors.
2. The probe of claim 1, wherein the ablation electrode tip
comprises a tubular-shaped metal shell.
3. The probe of claim 1, wherein the interior lumen of the ablation
electrode tip includes a proximal fluid chamber and a distal fluid
chamber, and wherein the proximal and distal fluid chambers are
separated by the distal tip insert and are fluidly coupled to each
other via the fluid channels.
4. The probe of claim 1, wherein distal tip insert comprises a
cylindrically-shaped insert body having a proximal section and a
distal section.
5. The probe of claim 4, wherein the fluid channels extend
lengthwise along the proximal section of the distal insert
body.
6. The probe of claim 1, wherein the ultrasonic imaging sensors are
disposed circumferentially about the distal tip insert.
7. The probe of claim 6, wherein the fluid channels are disposed
circumferentially about the distal tip insert.
8. The probe of claim 7, wherein the fluid channels are
circumferentially offset from the ultrasonic imaging sensors.
9. The probe of claim 1, further comprising an elongate probe body
coupled to the ablation electrode tip.
10. The probe of claim 1, further comprising a proximal tip insert
coupling a distal section of the elongate probe body to the
ablation electrode tip.
11. The probe of claim 1, further comprising a plurality of
irrigation ports disposed through the ablation electrode tip.
12. The probe of claim 11, wherein the irrigation ports are located
about the ablation electrode tip distally and/or proximally of the
acoustic openings.
13. The probe of claim 1, wherein the ultrasonic imaging sensors
comprise a plurality of laterally-facing ultrasonic imaging sensors
configured for transmitting ultrasonic waves from a side of the
ablation electrode tip.
14. The probe of claim 13, wherein the literally-facing ultrasonic
imaging sensors are each coupled to one of the plurality recesses
within the distal tip insert.
15. The probe of claim 1, wherein the ultrasonic imaging sensors
comprise at least one distally-facing ultrasonic imaging sensor
configured for transmitting ultrasonic waves in a distal
direction.
16. The probe of claim 15, wherein the distal-facing ultrasonic
imaging sensor is coupled to an internal bore within the distal tip
insert.
17. An ablation probe for treating and imaging body tissue, the
ablation probe comprising: an elongate probe body having a proximal
section and a distal section; an ablation electrode tip coupled to
the distal section of the elongate probe body, the ablation
electrode tip including an ablation electrode configured for
delivering ablation energy to body tissue; a plurality of acoustic
openings disposed through the ablation electrode tip; a distal tip
insert disposed within an interior lumen of the ablation electrode
tip, the distal tip insert separating the interior lumen into a
proximal fluid chamber and a distal fluid chamber; a plurality of
laterally-facing ultrasonic imaging sensors each coupled to a
corresponding recess within the distal tip insert, the
laterally-facing ultrasonic imaging sensors each configured to
transmit ultrasonic waves from a side of the ablation electrode tip
a plurality of fluid channels disposed about an outer extent of the
distal tip insert and circumferentially offset from the ultrasonic
imaging sensors; and a distally-facing ultrasonic imaging sensor
coupled to the distal insert, the distally-facing ultrasonic
imaging sensor configured for transmitting ultrasonic waves in a
forward direction away from a distal end of the ablation electrode
tip.
18. An ablation and ultrasound imaging system, comprising: a probe
configured for delivering ablation energy to body tissue, the probe
comprising: an ablation electrode tip; a plurality of acoustic
openings disposed through the ablation electrode tip; a distal tip
insert disposed within an interior lumen of the ablation electrode
tip, the distal tip insert including a plurality of fluid channels;
and a plurality of ultrasonic imaging sensors coupled to the distal
tip insert, the ultrasonic imaging sensors configured to transmit
ultrasonic waves through the acoustic openings, wherein the distal
tip insert includes a plurality of recesses each configured for
receiving one of the plurality of ultrasonic imaging sensors; an
ablation therapy module comprising an ablation source configured to
generate and supply an electrical signal to the ablation electrode
tip; and an ultrasound imaging module comprising an image processor
configured to process ultrasonic imaging signals received from the
ultrasonic imaging sensors to generate an ultrasonic image.
19. The system of claim 18, wherein the ultrasonic imaging module
further comprises: a signal generator configured to generate
control signals for controlling each ultrasonic imaging sensor.
Description
TECHNICAL FIELD
The present disclosure relates generally to devices and systems for
imaging tissue within the body during an ablation procedure. More
specifically, the present disclosure relates to an ablation probe
with ultrasonic imaging capabilities.
BACKGROUND
In ablation therapy, it is often necessary to determine various
characteristics of body tissue at a target ablation site within the
body. In interventional cardiac electrophysiology (EP) procedures,
for example, it is often necessary for the physician to determine
the condition of cardiac tissue at a target ablation site in or
near the heart. During some EP procedures, the physician may
deliver a mapping catheter through a main vein or artery into an
interior region of the heart to be treated. Using the mapping
catheter, the physician may then determine the source of a cardiac
rhythm disturbance or abnormality by placing a number of mapping
elements carried by the catheter into contact with the adjacent
cardiac tissue and then operate the catheter to generate an
electrophysiology map of the interior region of the heart. Once a
map of the heart is generated, the physician may then advance an
ablation catheter into the heart, and position an ablation
electrode carried by the catheter tip near the targeted cardiac
tissue to ablate the tissue and form a lesion, thereby treating the
cardiac rhythm disturbance or abnormality. In some techniques, the
ablation catheter itself may include a number of mapping
electrodes, allowing the same device to be used for both mapping
and ablation.
Various ultrasound-based imaging catheters and probes have been
developed for directly visualizing body tissue in applications such
as interventional cardiology, interventional radiology, and
electrophysiology. For interventional cardiac electrophysiology
procedures, for example, ultrasound imaging devices have been
developed that permit the visualization of anatomical structures of
the heart directly and in real-time. In some electrophysiology
procedures, for example, ultrasound catheters may be used to image
the intra-atrial septum, to guide transseptal crossing of the
atrial septum, to locate and image the pulmonary veins, and to
monitor the atrial chambers of the heart for signs of a perforation
and pericardial effusion.
Many ultrasound-based imaging systems comprise an imaging probe
that is separate from the mapping and ablation catheters used to
perform therapy on the patient. As a result, a position tracking
system is sometimes used to track the location of each device
within the body. In some procedures, it may be difficult for the
physician to quickly and accurately determine the condition of
tissue to be ablated. Moreover, the images obtained using many
ultrasound-based imaging systems are often difficult to read and
understand without reference to images obtained from a separate
imaging system such as a fluoroscopic imaging system.
SUMMARY
The present disclosure relates generally to devices and systems for
imaging anatomical structures within the body during an ablation
procedure.
In Example 1, an ablation probe for treating and imaging body
tissue comprises: an ablation electrode tip including an ablation
electrode configured for delivering ablation energy to body tissue;
a plurality of acoustic openings disposed through the ablation
electrode tip; a distal tip insert disposed within an interior
lumen of the ablation electrode tip, the distal tip insert
including a plurality of fluid channels; and a plurality of
ultrasonic imaging sensors coupled to the distal tip insert, the
ultrasonic imaging sensors configured to transmit ultrasonic waves
through the acoustic openings.
In Example 2, the probe according to Example 1, wherein the
ablation electrode tip comprises a tubular-shaped metal shell.
In Example 3, the probe according to any of Examples 1 or 2,
wherein the distal tip insert includes a plurality of recesses each
configured for receiving an ultrasonic imaging sensor.
In Example 4, the probe according to any of Examples 1-3, wherein
the interior lumen of the ablation electrode tip includes a
proximal fluid chamber and a distal fluid chamber, and wherein the
proximal and distal fluid chambers are separated by the distal tip
insert and are fluidly coupled to each other via the fluid
channels.
In Example 5, the probe according to any of Examples 1-4, wherein
distal tip insert comprises a substantially cylindrically-shaped
insert body having a proximal section and a distal section.
In Example 6, the probe according to Example 5, wherein the fluid
channels extend lengthwise along the proximal section of the distal
insert body.
In Example 7, the probe of according to any of Examples 1-5,
wherein the ultrasonic imaging sensors are disposed
circumferentially about the distal tip insert.
In Example 8, the probe according to any of Examples 1-7, wherein
the fluid channels are disposed circumferentially about the distal
tip insert.
In Example 9, the probe according to any of Examples 1-8, wherein
the fluid channels are circumferentially offset from the ultrasonic
imaging sensors.
In Example 10, the probe according to any of Examples 1-9, further
comprising an elongate probe body coupled to the ablation electrode
tip.
In Example 11, the probe according to any of Examples 1-10, further
comprising a proximal tip insert coupling a distal section of the
elongate probe body to the ablation electrode tip.
In Example 12, the probe according to any of Examples 1-11, further
comprising a plurality of irrigation ports disposed through the
ablation electrode tip.
In Example 13, the probe according to Example 12, wherein the
irrigation ports are located about the ablation electrode tip
distally and/or proximally of the acoustic openings.
In Example 14, the probe according to any of Examples 1-13, wherein
the ultrasonic imaging sensors comprise a plurality of
laterally-facing ultrasonic imaging sensors configured for
transmitting ultrasonic waves from a side of the ablation electrode
tip.
In Example 15, the probe according to Example 14, wherein the
laterally-facing ultrasonic imaging sensors are each coupled to a
recess within the distal tip insert.
In Example 16, the probe according to any of Examples 1-15, wherein
the ultrasonic imaging sensors comprise at least one
distally-facing ultrasonic imaging sensor configured for
transmitting ultrasonic waves in a forward direction away from a
distal end of the ablation electrode tip.
In Example 17, the probe according to Example 16, wherein the
distal-facing ultrasonic imaging sensor is coupled to an internal
bore within the distal tip insert.
In Example 18, an ablation probe for treating and imaging body
tissue comprises: an elongate probe body having a proximal section
and a distal section; an ablation electrode tip coupled to the
distal section of the elongate probe body, the ablation electrode
tip including an ablation electrode configured for delivering
ablation energy to body tissue; a plurality of acoustic openings
disposed through the ablation electrode tip; a distal tip insert
disposed within an interior lumen of the ablation electrode tip,
the distal tip insert separating the interior lumen into a proximal
fluid chamber and a distal fluid chamber; a plurality of
laterally-facing ultrasonic imaging sensors each coupled to a
corresponding recess within the distal tip insert, the
laterally-facing ultrasonic imaging sensors each configured to
transmit ultrasonic waves from a side of the ablation electrode
tip; a plurality of fluid channels disposed about an outer extent
of the distal tip insert and circumferentially offset from the
ultrasonic imaging sensors; and a distally-facing ultrasonic
imaging sensor coupled to the distal insert, the distally-facing
ultrasonic imaging sensor configured for transmitting ultrasonic
waves in a forward direction away from a distal end of the ablation
electrode tip.
In Example 19, an ablation and ultrasound imaging system comprises:
a probe configured for delivering ablation energy to body tissue,
the probe comprising an ablation electrode tip, a plurality of
acoustic openings disposed through the ablation electrode tip, a
distal tip insert disposed within an interior lumen of the ablation
electrode tip, the distal tip insert including a plurality of fluid
channels, and a plurality of ultrasonic imaging sensors coupled to
the distal tip insert, the ultrasonic imaging sensors configured to
transmit ultrasonic waves through the acoustic openings; an
ablation therapy module configured for generating and supplying an
electrical signal to the ablation electrode tip; and an ultrasound
imaging module configured for processing ultrasonic imaging signals
received from the ultrasonic imaging sensors.
In Example 20, the system according to Example 19, wherein the
ultrasonic imaging module comprises: a signal generator configured
to generate control signals for controlling each ultrasonic imaging
sensor; and an image processor configured for processing electrical
signals received from each ultrasonic imaging sensor and generating
a plurality of ultrasonic images.
While multiple embodiments are disclosed, still other embodiments
of the present invention will become apparent to those skilled in
the art from the following detailed description, which shows and
describes illustrative embodiments of the invention. Accordingly,
the drawings and detailed description are to be regarded as
illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a combined ablation and imaging
system in accordance with an illustrative embodiment;
FIG. 2 is a perspective view showing the distal section of the
combined ablation and ultrasonic imaging probe of FIG. 1 in greater
detail;
FIG. 3 is a cross-sectional view of the ablation electrode tip;
FIG. 4 is a cross-sectional view of the ablation electrode tip
along line 4-4 in FIG. 2;
FIG. 5 is a cross-sectional view of the RF electrode along line 5-5
in FIG. 2;
FIG. 6 is a perspective view of the proximal tip insert of FIG.
3;
FIG. 7 is a perspective view of the distal tip insert of FIG.
3;
FIG. 8 is an end view of the distal tip insert of FIG. 7 along line
8-8 in FIG. 7; and
FIG. 9 is a cross-sectional view of the distal tip insert along
line 9-9 in FIG. 7.
While the invention is amenable to various modifications and
alternative forms, specific embodiments have been shown by way of
example in the drawings and are described in detail below. The
intention, however, is not to limit the invention to the particular
embodiments described. On the contrary, the invention is intended
to cover all modifications, equivalents, and alternatives falling
within the scope of the invention as defined by the appended
claims.
DETAILED DESCRIPTION
FIG. 1 is a schematic view of a combined ablation and imaging
system 10 in accordance with an illustrative embodiment. As shown
in FIG. 1, the system 10 includes a combined ablation and
ultrasonic imaging probe 12, an RF generator 14, a fluid reservoir
and pump 16, and an ultrasonic imaging module 18. The probe 12
comprises an elongate probe body 20 having a proximal section 22
equipped with a handle assembly 24, and a deflectable distal
section 26 including an ablation electrode tip 28. The probe body
20 includes an internal cooling fluid lumen 29 fluidly coupled to
the fluid reservoir and pump 16, which supplies a cooling fluid,
such as saline, through the probe body 20 to a number of irrigation
ports 30 in the ablation electrode tip 28. The probe body 20 may
further include additional lumens or other tubular elements for
supporting electrical conductors, additional fluid lumens, a
thermocouple, an insertable stylet, as well as other components. In
some embodiments, the probe body 20 comprises flexible plastic
tubing with a braided metal mesh to increase the rotational
stiffness of the body 20.
The RF generator 14 is configured for generating RF energy for
performing ablation procedures using the ablation electrode tip 28.
The RF generator 14 includes an RF energy source 32 and a
controller 34 for controlling the timing and level of the RF energy
delivered by the tip 28. During an ablation procedure, the RF
generator 14 is configured to deliver ablation energy to the tip 28
in a controlled manner to ablate any sites identified or targeted
for ablation. Other types of ablation sources in addition to or in
lieu of the RF generator 14 can also be used for ablating target
sites. Examples of other types of ablation sources can include, but
are not limited to, microwave generators, acoustic generators,
cryoablation generators, and laser/optical generators.
The ultrasonic imaging module 18 is configured for generating high
resolution ultrasonic images (e.g., A, M, or B-mode images) of
anatomical structures within the body based on signals received
from several ultrasonic imaging sensors 36 located within the probe
tip 28. In the embodiment of FIG. 1, the ultrasonic imaging module
18 includes an ultrasonic signal generator 40 and an image
processor 42. The ultrasonic signal generator 40 is configured to
provide electrical signals for controlling each of the ultrasonic
sensors 36. The imaging signals received back from the ultrasonic
imaging sensors 36, in turn, are fed to the image processor 42,
which processes the signals and generates images that can be
displayed on a graphical user interface (GUI) 44. In certain
embodiments, for example, the ultrasonic images displayed on the
GUI 44 can be used to assist the physician with advancing the probe
12 through the body and to perform an ablation procedure. In
cardiac ablation procedures, for example, the ultrasonic images
generated from the ultrasound signals can be used to confirm tissue
contact of the probe 12 within the heart or surrounding anatomy, to
determine the orientation of the probe 12 within the body, to
determine the tissue depth of the tissue at a target ablation site,
and/or to visualize the progression of a lesion being formed in the
tissue.
Various characteristics associated with the ultrasonic imaging
sensors 36 as well as the circuitry within the ultrasonic imaging
module 18 can be controlled to permit the sensors 36 to accurately
detect tissue boundaries (e.g., blood or other bodily fluids),
lesion formation and progression, as well as other characteristics
of the tissue before, during, and/or after the ablation procedure.
Example tissue characteristics that can be visualized using the
probe 12 include, but are not limited to, the presence of fluid
vaporization inside the tissue, the existence of a prior scar, the
size and shape of a lesion being formed, as well as structures
adjacent to heart tissue (e.g., lungs, esophagus). The depth at
which the ultrasonic imaging sensors 36 can visualize anatomical
structures within the body is dependent on the mechanical
characteristics of the sensors 36, the electrical characteristics
of the sensor circuitry including the drive frequency of the signal
generator 40, the boundary conditions and degree of attenuation
between the sensors 36 and the surrounding anatomy, as well as
other factors.
In some embodiments, the probe 12 further includes a steering
mechanism to permit the operator to deflect and steer the probe 12
within the body. In one embodiment, for example, a steering member
such as a steering knob 46 rotatably coupled to the handle 24 can
be used to deflect the ablation electrode tip 28 in one or multiple
directions relative to a longitudinal axis of the probe body 20.
Rotational movement of the steering knob 46 in a first direction
relative to the handle 24 causes a steering wire within the probe
body 20 to move proximally relative to the probe body 20, which, in
turn, bends the distal section 26 of the probe body 20 into a
particular shape such as an arced shape. Rotational movement of the
steering knob 46 in the opposite direction, in turn, causes the
distal section 26 of the probe body 20 to return to its original
shape, as shown. To assist in the deflection, and in some
embodiments, the probe body 20 includes one or more regions made of
a lower durometer material than the other portions of the probe
body 20.
Although the system 10 is described in the context of a medical
system for use in intracardiac electrophysiology procedures for
diagnosing and treating the heart, in other embodiments the system
10 may be used for treating, diagnosing, or otherwise visualizing
other anatomical structures such as the prostate, brain, gall
bladder, uterus, esophagus, and/or other regions in the body.
Moreover, many of the elements in FIG. 1 are functional in nature,
and are not meant to limit the structure that performs these
functions in any manner. For example, several of the functional
blocks can be embodied in a single device or one or more of the
functional blocks can be embodied in multiple devices.
FIG. 2 is a perspective view showing the distal section 26 of the
probe 12 of FIG. 1 in greater detail. As can be further seen in
FIG. 2, the ablation electrode tip 28 includes an RF ablation
electrode 48 configured for delivering ablation energy to body
tissue surrounding the tip 28. In the embodiment of FIG. 2, the RF
ablation electrode 48 comprises a tubular-shaped metal shell that
extends from a distal end 50 of the probe body 20 to a distal end
52 of the tip 28. A number of exposed openings 54a, 54b, 54c
disposed through the ablation electrode tip 28 form acoustic
openings that permit ultrasonic waves transmitted by the ultrasonic
imaging sensors 36a, 36b, 36c, 36d to pass through the tip 28 and
into the surrounding tissue. The reflected ultrasonic waves
received back from the tissue pass through the acoustic openings
54a, 54b, 54c and are sensed by the ultrasonic imaging sensors 36a,
36b, 36c, 36d operating in a receive mode. In some embodiments, the
acoustic openings 54a, 54b, 54c comprise exposed openings or
apertures formed through the wall of the ablation electrode tip
28.
In addition to serving as an ablation electrode, the RF ablation
electrode 48 also functions as a housing that contains the
ultrasonic imaging sensors 36a, 36b, 36c, 36d, the electrical
conductors coupling the RF ablation electrode 48 to the RF
generator 14, the electrical conductors coupling the ultrasonic
imaging sensors 36a, 36b, 36c, 36d to the ultrasonic imaging module
18, one or more steering wires of the steering mechanism, as well
as other components. In certain embodiments, the RF ablation
electrode 48 comprises an electrically conductive alloy such as
platinum-iridium, which in addition to serving as an electrode for
providing ablation therapy, is also used as a fluoroscopic marker
to determine the location of the ablation electrode tip 28 within
the body using fluoroscopy.
In the embodiment of FIG. 2, the probe 12 includes a distal-facing
ultrasonic imaging sensor 36a located at or near the distal end 52
of the ablation electrode tip 28. In other embodiments, multiple
distal-facing ultrasonic imaging sensors 36a are located at or near
the distal end 52 of the ablation electrode tip 28. Each ultrasonic
sensor 36a is configured to transmit ultrasonic waves primarily in
a forward or distal direction away from the distal end 52 of the
ablation electrode tip 28. A second set of ultrasonic imaging
sensors 36b, 36c, 36d disposed within the tip 28 at a location
proximal to the distal-facing ultrasonic imaging sensor 36a are
configured to transmit ultrasonic waves primarily in a lateral or
side-facing direction away from the side of the ablation electrode
tip 28. The reflected waves received back from the ultrasonic
imaging sensors 36a, 36b, 36c, 36d produces signals that can be
used by the ultrasonic imaging module 18 to generate images of the
surrounding body tissue.
In some embodiments, the ultrasonic imaging sensors 36a, 36b, 36c,
36d each comprise piezoelectric transducers formed of a
piezoceramic material such as lead zirconate titanate (PZT) or a
piezoelectric polymer such as polyvinylidene fluoride (PVDF). In
some embodiments, the ablation electrode tip 28 includes three
laterally-facing ultrasonic imaging sensors 36b, 36c, 36d each
oriented circumferentially at 120.degree. intervals apart from each
other about the tip 28 for use in imaging tissue located adjacent
to the sides of the tip 28. In other embodiments, a greater or
lesser number of laterally-facing ultrasonic imaging sensors are
employed for imaging tissue adjacent to the sides of the probe tip
28.
In the embodiment of FIG. 2, the ablation electrode tip 28 has an
open irrigated configuration including a number of irrigation ports
30 used to deliver cooling fluid to cool the tip 28 and the
surrounding tissue. In other embodiments, the ablation electrode
tip 28 has a closed irrigation configuration in which the cooling
fluid is recirculated through the tip 28 without being ejected into
the surrounding tissue. In some embodiments, the ablation electrode
tip 28 comprises six irrigation ports 30 each disposed
circumferentially at 60.degree. intervals apart from each other
about the tip 28 and at a location proximal to the distal-facing
ultrasonic sensor 36a and distal to the location of the
laterally-facing ultrasonic sensors 36b, 36c, 36d. In other
embodiments, a greater or lesser number of fluid irrigation ports
30 are employed. In some embodiments, the fluid irrigation ports 30
are circular in shape, and have a diameter in the range of
approximately 0.005 inches to 0.02 inches. The size, number, and/or
positioning of the irrigation ports 30 can vary, however. In some
embodiments, for example, the ablation electrode tip 28 further
includes a number of fluid irrigation ports 30 located
circumferentially about the tip 28 proximally of the
laterally-facing ultrasonic imaging sensors 36b, 36c, 36d. During
ablation therapy, the cooling fluid is used to control the
temperature and reduce coagulum formation on the ablation electrode
tip 28, thus preventing an impedance rise of the tissue in contact
with the tip 28 and increasing the transfer of RF ablation energy
delivered from the tip 28 into the tissue.
FIG. 3 is a cross-sectional view of the ablation electrode tip 28.
As can be further seen in FIG. 3, the ablation electrode tip 28
includes an interior lumen 56 that houses the ultrasonic imaging
sensors 36a, 36b, 36c, 36d, electrical conduits 58, 60, 62, 63 for
transmitting power to and receiving signals back from the sensors
36a, 36b, 36c, 36d, and an electrical conduit 64 for supplying RF
ablation energy to the RF electrode 48. In some embodiments, the
electrical conduits 58, 60, 62, 63, 64 comprise insulated tubular
members that contain wire leads used to electrically connect the RF
generator 14 to the RF electrode 48 and the ultrasonic imaging
module 18 to the ultrasonic imaging sensors 36a, 36b, 36c, 36d. A
fluid conduit 66 extending through the probe 12 supplies cooling
fluid from the fluid reservoir and pump 16 to the interior lumen 56
of the ablation electrode tip 28, which is then transmitted into
the surrounding tissue through the irrigation ports 30. A
thermocouple lead 68 extending through the probe 12 terminates
distally at a thermocouple 70 located within the interior lumen 56
for sensing the temperature of the ablation electrode tip 28 during
the ablation procedure.
A proximal tip insert 72 is used for coupling the ablation
electrode tip 28 to the distal end 50 of the probe body 20. A
distal tip insert 74 is configured to support the laterally-facing
ultrasonic imaging sensors 36b, 36c, 36d within the ablation
electrode tip 28, and divides the interior lumen 56 into a proximal
fluid chamber 76 and a distal fluid chamber 78. A number of fluid
channels 80 extending lengthwise along the length of the distal tip
insert 74 fluidly connect the proximal fluid chamber 76 to the
distal fluid chamber 78. During ablation, the presence of the
distal tip insert 74 within the ablation electrode tip 28 creates a
back pressure as the cooling fluid enters the proximal fluid
chamber 76, causing the fluid to circulate before being forced
through the channels 80 and into the distal fluid chamber 78.
FIG. 4 is a cross-sectional view of the ablation electrode tip 28
along line 4-4 in FIG. 3. As can be further seen in conjunction
with FIG. 4, and in some embodiments, the distal tip insert 74
includes three fluid channels 80 for supplying cooling fluid from
the proximal fluid chamber 76 to the distal fluid chamber 78. As
can be further seen in FIG. 4, and in some embodiments, the
ablation electrode tip 28 includes three laterally-facing
ultrasonic imaging sensors 36b, 36c, 36d equally spaced from each
other at an angle .alpha. of 120.degree. about the circumference of
the distal tip insert 74. Although three laterally-facing
ultrasonic sensors 36b, 36c, 36d are shown in the embodiment of
FIG. 4, a greater or lesser number of ultrasonic imaging sensors
may be employed. By way of example and not limitation, four
ultrasonic imaging sensors may be disposed at equidistant angles
.alpha. of 90.degree. about the circumference of the distal tip
insert 74. During imaging, the use of multiple laterally-facing
ultrasonic imaging sensors 36b, 36c, 36d spaced about the
circumference of the distal tip insert 74 ensures that the field of
view of at least one of the sensors 36b, 36c, 36d is in close
proximity to the target tissue irrespective of the tip orientation
relative to the target tissue. Such configuration also permits the
physician to easily visualize the target tissue without having to
rotate the probe 12 once the probe 12 is in contact with the
tissue.
To conserve space within the ablation electrode tip 28, the fluid
channels 80 are each circumferentially offset from the ultrasonic
imaging sensors 36b, 36c, 36d. In the embodiment shown in which
three laterally-facing ultrasonic imaging sensors 36b, 36c, 36d are
employed, each of the fluid channels 80 are disposed
circumferentially at equidistant angles .beta..sub.1 of 120.degree.
about the circumference of the distal tip insert 74, and are
circumferentially offset from each adjacent ultrasonic imaging
sensor by an angle R2 of approximately 60.degree. . The angle
.beta..sub.1 between each of the fluid channels 80 and the angle
.beta..sub.2 between each fluid channel 80 and adjacent ultrasonic
imaging sensor 36b, 36c, 36d can vary in other embodiments
depending on the number of fluid channels and/or ultrasonic imaging
sensors provided. In some embodiments, the fluid channels 80 each
have an equal cross-sectional area and are equally positioned
around the center of the distal tip insert 74. The number and
configuration of the fluid channels can vary. In one embodiment,
for example, the fluid channels are circumferentially aligned with
the acoustic pathway of the ultrasonic imaging sensors in the
manner described, for example, in co-related U.S. Pat. No.
8,945,015, entitled "Ablation Probe With Fluid-Based Acoustic
Coupling For Ultrasonic Tissue Imaging," the contents of which are
incorporated herein by reference in their entirety for all
purposes.
FIG. 5 is a cross-sectional view of the RF electrode 48 along line
5-5 in FIG. 2. As can be further seen in FIG. 5, the RF electrode
48 comprises a tubular-shaped shell 82 including six irrigation
ports 30 equally spaced from each other at an angle .phi. of
60.degree. about the circumference of the shell 82. The number,
size, and angle .phi. between each of the irrigation ports 30 can
vary in other embodiments. To minimize interference of the
irrigation fluid with the transmission of ultrasonic waves from the
ultrasonic imaging sensors 36, and in some embodiments, the centers
of the irrigation ports 30 are offset circumferentially from the
centers of the side-facing acoustic openings 54b, 54c. In those
embodiments in which the ablation electrode tip 28 includes three
lateral-facing ultrasonic imaging sensors 36b, 36c, 36d and six
irrigation ports 30, for example, the irrigation ports 30 can be
circumferentially offset from each adjacent side acoustic opening
54b, 54c by an angle of approximately 30.degree.. This
circumferential offset may vary in other embodiments depending on
the number and configuration of imaging sensors 36 as well as other
factors. In some embodiments, the irrigation ports 30 are circular
in shape, and have a diameter within a range of approximately 0.005
to 0.02 inches.
FIG. 6 is a perspective view of the proximal tip insert 72 of FIG.
3. As can be further seen in FIG. 6, the proximal tip insert 72
comprises a hollow metal insert body 84 having a proximal section
86 and a distal section 88. The proximal section 86 is configured
to attach to the distal end 50 of the probe body 20. The distal
section 88, in turn, has an enlarged outer diameter relative to the
proximal section 86, and is configured to attach to the RF
electrode shell 82. In some embodiments, the proximal tip insert 72
is coupled to both the distal end 50 of the probe body 20 and to
the RF electrode shell 82 via frictional fit, solder, welding,
and/or an adhesive attachment. A shoulder 90 at the transition from
the proximal section 86 to the distal section 88 serves as a flange
to align the distal end 50 of the probe body 20 flush with the RF
electrode shell 82.
A first lumen 92 disposed through the proximal tip insert 72
provides a conduit for the electrical and fluid conduits 58, 60,
62, 64, 66 that supply electrical signals and cooling fluid to the
ablation electrode tip 28. A second lumen 94 disposed through the
proximal tip insert 72 provides a conduit for the steering
mechanism used for deflecting the probe 12.
FIG. 7 is a perspective view of the distal tip insert 74 of FIG. 3.
As shown in FIG. 7, the distal tip insert 74 comprises a
cylindrically-shaped metal body 98 having a proximal section 100
and a distal section 102. In the embodiment of FIG. 7, the outer
extent 104 of the proximal section 100 is sized to fit within the
RF electrode shell 82 adjacent to the location of the side acoustic
openings 54b, 54c, and includes three fluid channels 80. The outer
extent 104 further includes a number of recesses 106 each
configured to receive a corresponding one of the lateral-facing
ultrasonic imaging sensors 36b, 36c, 36d therein. In some
embodiments, the recesses 106 are sized and shaped to receive the
ultrasonic imaging sensors 36b, 36c, 36d such that the sensors 36b,
36c, 36d lie substantially flush with the outer extent 104. An
exposed opening 108 located at the proximal end of the distal tip
insert 74 provides a channel to feed the electrical conduits for
the ultrasonic imaging sensors 36b, 36c, 36d into the recesses
106.
The distal section 102 of the distal tip insert 74 is configured to
support the distal-facing ultrasonic imaging sensor 36a within the
ablation electrode tip 28. The outer extent 110 of the distal
section 102 is reduced in diameter relative to the proximal section
100. This reduction in diameter creates an annular-shaped distal
fluid chamber 78 (see FIG. 3) that receives cooling fluid via the
fluid channels 80.
An aperture 112 within the proximal section 100 of the insert body
98 is configured to receive the distal end of a thermocouple used
for sensing the temperature of the ablation electrode tip 28. As
can be further seen in FIGS. 8-9, a second, central bore 114
extending through the proximal and distal sections 108, 110 of the
insert body 104 is configure to receive the distal-facing
ultrasonic imaging sensor 36a and a portion of the electrical
conduit 63 that connects the sensor 36a to the ultrasonic imaging
module 18. In some embodiments, a number of side apertures 116
disposed through the distal section 102 are used to permit
alignment and mounting of the distal-facing ultrasonic imaging
sensor 36a.
Various modifications and additions can be made to the exemplary
embodiments discussed without departing from the scope of the
present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the described features.
Accordingly, the scope of the present invention is intended to
embrace all such alternatives, modifications, and variations as
fall within the scope of the claims, together with all equivalents
thereof.
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